Criteria for Approval of Research

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Criteria for Approval of Research

• Ann Johnson, M.P.H.
• IRB Administrator, University of Utah
• June 4, 2008

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Belmont Report

• Respect for Persons ? Informed consent
• Beneficence ? Risks and Benefits
• Justice ? Selection of Subjects

http//ohsr.od.nih.gov/guidelines/belmont.html
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Who is a Participant?

• A Person
• A Medical Chart
• A Blood or Tissue Sample
• A Record about a Person
• Example If a study involves reviewing records,
  interviewing faculty, and observing students,
  there are 3 groups of participants.

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1. Minimize Risk

• Risks to subjects must be minimized
• Use procedures with sound research design
• Procedures do not expose participants to
  unnecessary risk
• Use standard of care procedures whenever possible

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2. Risk Benefit Ratio

• Risk Benefit ratio must be appropriate
• Evaluate only the risks from the research, not
  standard of care
• Evaluate reasonable benefits, not long-range
  effects
• Consider appropriate risk for children

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3. Equitable Selection of Subjects

• Consider the purpose and setting of the research.
• Are vulnerable populations included? Should they
  be included?
• Provisions to include non-English speaking
  participants.

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4. Informed Consent

• Informed consent (or assent) must be sought from
  a participant or an LAR
• Except when a waiver is appropriate
• Consent documented appropriately
• Except when a waiver is appropriate
• Consent Process
• Required Elements of Informed Consent

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5. Data Monitoring

• Where appropriate, the research plan makes
  provisions for monitoring the data to ensure the
  safety of participants.
• Can vary depending on the level of risk.
• All studies are required to report
• Unanticipated problems involving risks to
• participants or others
• Adverse Events
• Non-compliance

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6. Privacy and Confidentiality

• Privacy of Subjects
• Reportable Diseases
• Genetic Research
• Sensitive Information
• Confidentiality of Data
• Tissue Banking
• Databases and Registries

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7. Vulnerable Populations

• More vulnerable to coercion or undue influence
• Additional safeguards should be included
• Think of the children!

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Questions or Comments?
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Understanding Consent Assent Requirements
Ann Johnson, M.P.H. IRB Administrator, University
of Utah June 4, 2008
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Consent for Participants

• Consent must be accounted for with all
  participants using
• A waiver of consent
• An alteration of consent
• A waiver of documentation of consent
• A signed consent document

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Waiver of Consent

• A waiver of consent is typically used when a PI
  wants to retrospectively review participant
  charts or records.

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Waiver of Consent

• Criteria for a waiver or alteration of consent
• The research involves no more than minimal risk
  to the subjects
• The waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• The research could not practicably be carried out
  without the waiver or alteration and
• Whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation.

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Alteration of Consent

• An alteration of consent requests that a consent
  requirement be altered or removed from the
  consent form/process.
• The alteration must be justified by the
  investigator.
• This is used with studies involving deception.

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Waiver of Documentation of Consent

• The PI is required to present the consent
  elements to the participant, but the participant
  is not required to sign a form.
• Examples
• The main risk to the participant would be
  potential harm resulting from a breach of
  confidentiality
• The procedure is minimal risk and is normally
  done without a signed consent form
• A questionnaire cover letter

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Consent Process Requirements

• Give the participant enough time to consider
  being in the study.
• It may be coercive not to give the participant
  enough time to decide.
• Minimize coercion and undue influence
• Power relationships
• Not just money Think of the children!

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Consent Process Requirements

• In a language the participant understands
• This is not just getting the consent form
  translated.
• A translator is needed to talk with the
  participants and answer any questions.
• No exculpatory language
• Waives or appears to waive the participants
  legal rights.
• Releases or appears to release the PI, sponsor,
  or institution from liability.

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Consent Process Requirements

• Who can give consent?
• Only the participant?
• A legal representative or guardian?
• Do both parents need to sign?
• Who else needs to be included?
• Investigator?
• A witness?
• A translator?

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Consent Documents

• A consent process and document should contain all
  of the element required in the criteria for
  approval.
• Requirements are the same for Parental Permission
  forms.

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Consent Form Requirements

• Background
• Does the form state that this is a research
  study?
• What are the purposes of this research?

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Consent Form Requirements

• Procedures
• How long will the participant be in the study?
• What procedures will be done?
• Which procedures are experimental and which are
  standard?

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Consent Form Requirements

• Risks
• What are the risks of participating?
• Medical risks of procedures
• Psychological risks of a positive test result,
• answering sensitive questions, etc.
• Confidentiality or Privacy risks
• Reproductive risks to a pregnant
• woman and/or fetus.

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Consent Form Requirements

• Benefits
• What are the reasonable benefits of
  participating?
• Sometimes there are no benefits to the
• participant.
• Compensation is not considered
• a benefit.

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Consent Form Requirements

• Alternative Procedures
• Are there any alternatives to participating in
  the study?
• Example A student can get course credit by
  participating in the study OR writing a paper.
• Example The patient can get experimental
  treatment A or standard treatment B.

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Consent Form Requirements

• Confidentiality and Privacy
• How will the participants information be
  protected?
• How will the participants privacy be protected?

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Consent Form Requirements

• Person to Contact IRB statement
• Who should the participant contact
• Questions, concerns, complaints
• If he/she is injured or harmed by being in the
• study

• What if the participant does not feel
• comfortable contacting the PI?
• The participant should know that
• he/she can call the IRB.

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Consent Form Requirements

• Research-Related Injury
• Is medical treatment and compensation available
  if the participant is injured by being in the
  study?

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Consent Form Requirements
Voluntary Participation

• Participation is voluntary.
• The participant can say no or stop
  participating
• at any time.

• Saying no or stopping will not affect normal
  care and will not cause penalty.

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Consent Form Requirements
Costs Compensation

• Does the participant have to pay for the
  procedures?
• Will someone else pay for the procedures?
• Will the participant get paid to be in the study?

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Consent Form Requirements
Other considerations

• Are there any unforeseeable risks?
• Can the PI withdraw the participant from the
  study? Under what circumstances?
• What are the procedures for withdrawing?
• What if significant new information arises during
  the research study?
• How many people will be enrolled in this study?

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Consent Form Requirements
Possible Signatures

• Participant
• Parent(s)
• Legally Authorized Representatives
• Person Obtaining Consent
• PI
• Witness

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Additional Considerations

• Databases and Registries
• Tissue Banking
• Genetic Testing
• Reportable Diseases
• Placebo Use

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Databases Registries

• Participants need to know
• Where the data will be kept?
• Who has access to the data?
• Will identifiers be recorded?
• Can they withdraw from participation?
• What will the data be used for?

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Tissue Banking

• Participants should have a choice about whether
  or not their tissues can be banked for future
  research.
• The type of future research should be specific to
  the type of study, disease, or treatment.

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Genetic Testing

• Will results of genetic tests be revealed to the
  participant?
• How will results be disclosed (in person,
  letter)?
• Who will disclose the results? What is their
  training?
• Who will answer questions about results?
• Are additional services available and who will
  pay for those services (the participant or the
  study)?
• How will associated risks be minimized?

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Reportable Diseases

• If a study will be testing for a reportable
  disease, the consent form should state that
  positive test results will be reported to the
  appropriate organization.
• How will results be given to the participant?
• What follow-up medical care will be given?
• Examples of reportable diseases
• HIV/AIDS
• Hepatitis A, B, C

• Tuberculosis
• Syphilis

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Assent

• Is child assent always required when research
  involves children?
• No. The IRB is responsible for deciding whether
  child assent is required in proposed research
  activities.

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Assent

• Child assent is required, except in the following
  three circumstances
• the capability of some or all of the children is
  so limited that they cannot reasonably be
  consulted
• the intervention or procedure involved in the
  research holds out the prospect of direct benefit
  to the health or well-being of the children and
  is available only in the context of the research
  
• the research meets the same conditions as those
  for waiver or alteration of informed consent in
  research involving adults.

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Assent

• Additional considerations if parental permission
  is to be waived
• How will researchers encourage each adolescent to
  seek the support of a parent or another adult
  prior to participation?
• What is the procedure to allow adolescents to
  seek assistance on a confidential basis after
  completing surveys containing questionnaires that
  may raise issues for which adolescents may desire
  further information or assistance?
• IOM Report 2004

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Assent

• For what age is assent required?
• There is no regulatory defined age. A general
  guideline is 6 or 7 years old to 17 years old.
• The IRB can decide what type of process and
  documentation are appropriate for each study.

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Points to Consider for Assent

• IOM Report 2004
• Attention should focus on the process of
  requesting parents permission and childrens
  assent.
• In some situations it may not be appropriate to
  document assent.

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Points to Consider for Assent

• IOM Report 2004
• The assent process should
• Be developmentally appropriate
• Give children a chance to say yes or no
• Clarify what degree of control the parent(s)
• have over the decision to participate
• Describe what information will be given to
• both parent(s) and child, parent only, or
  child
• only

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Age Appropriate Assent

• IOM Report 2004
• What is the study about? Will it help?
• What will happen and when?
• What discomfort will there be and how will
• it be minimized?
• Who will answer the childs questions?
• Does the child have the option to say no?

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Questions or Comments?ann.johnson_at_hsc.utah.edu
www.research.utah.edu/irb